Sadra Medical Inc (a subsidiary of Boston Scientific Corporation)

  • 제조사 모회사 (2017)
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NZMMDSA
  • 3 Events

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 3 건

  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: LOTUS TAVR 25mm H749LTV250, LOTUS TAVR 25mm H749LTV250, LOTUS TAVR 27mm H749LTV270
  • 모델명 / 제조번호(시리얼번호)
    Model: H749LTV230, H749LTV250, H749LTV270, Affected: Multiple lots
  • 모델명 / 제조번호(시리얼번호)
    Model: H749LTV230, H49LTV250, H749LTV270, Affected: All Batches